Need Change Control Yes/No Decision Tree Template

#1
I'm trying to put together a decision tree with yes/no's that lead to the correct decision with change control whether an employee should take the route of opening a change order for a validation or submit a simple document change request. They need to be very simple direct questions where there is no room for interpretation. Can you recommend a good template, resource or website to go to? My company is looking for a decision tree. Thanks
 
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Bev D

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#2
Does the change effect the sequence, timing, methods or other elements of the manufacturing or testing process? Yes - validate. No - second question: Does the change alter the product or the materials that go into the product in any way? Yes - Validate. No - change order.

Now some will say that is too restrictive. But it is simple and meets your needs to restrict interpretation and thought.

The fundamental requirement for validation is not really the intended effect but the unintended effect. Too many people step right over that. I’ve seen many engineers and scientists spend more time rationalizing why they don’t need to validate than it would have taken to just do the testing. ~9 of 10 times nothing bad happens - but when that one time does occur it takes more time, money and negative customer experience than all of the 9 times saved. By far. IF you have really well fully characterized processes and designs simple first article type testing is all that is required. BUT that is a rare state.

Let me give an example. Just this year a resin supplier decided to remove the wax from its resin in order to save money. The plastic injection molders did test the resin to ensure that it didn’t effect processing. BUT many users of the many different molded parts didn’t validate the parts in their systems. Because really what could possibly go wrong? Well we did validate one of our parts and it stuck upon insertion. Couldn’t insert the part at all. Oops. The removal of the wax altered the surface properties of the molded part in a way that wasn’t tested. But the results were catastrophic. We recently discovered another part that was ‘off the shelf’ and it too sticks in use, rendering it useless. Validate. Always validate.
 
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